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The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low carbohydrate diet
Calori restricted diet
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Low carbohydrate diet

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes diagnosis ≧ 1 year
  • poorly controlled with HbA1c≧ 7.5% in the previous 3 months.
  • aged 20 to 80
  • without or with treatment [ oral hypoglycemic agents (OHA) and/or insulin treatment)

Exclusion Criteria:

  • pregnancy or lactating women
  • impaired renal function with serum creatinine ≧ 1.5 mg/dl
  • abnormal liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis
  • significant heart diseases (unstable angina, unstable heart failure)
  • frequent gout attacks (≧ 3 times/year)
  • participation in other weight loss programs or the use of weight-reducing drugs
  • eating disorders
  • could not complete the questionnaire
  • poor compliance to protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Low carbohydrate diet

    Calori restricted diet

    Arm Description

    Low carbohydrate diet limits carbohydrate <=90g/day

    Traditional diabetic diet

    Outcomes

    Primary Outcome Measures

    The improvement of glycemic control status
    The reduction of HbA1c, fasting and 2-h glucose over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    The reduction of medication effect score (MES)
    The MES assessed the overall utilization of hypoglycemic agents. The percentage of the maximum daily dose for each medication was multiplied by an adjustment factor and these products were summed to produce the final MES value. A higher MES value denoted a greater use of medication. The minimum score is 0 and without maximum score.The lower, the better. The reduction of MES over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.

    Secondary Outcome Measures

    The improvement of lipid profile
    The reduction of total cholesterol, triglyceride, LDL and the increment of HDL after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    The improvement of small dense low density lipoprotein (sdLDL)
    The reduction of sdLDL after intervention.The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    The maintenance of renal function
    The change of serum creatinine after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    The improvement of microalbuminuria.
    The reduction of microalbumin/creatine ratio after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    The improvement of carotid intima-media thickness (IMT)
    The reduction of carotid IMT after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.

    Full Information

    First Posted
    May 31, 2017
    Last Updated
    September 30, 2018
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03176056
    Brief Title
    The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus
    Official Title
    Low Carbohydrate Diet for Type 2 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2, 2016 (Actual)
    Primary Completion Date
    January 28, 2018 (Actual)
    Study Completion Date
    January 28, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study determines whether an educational intervention with a 90 g/day LCD is safe, effective and has good compliance for poorly controlled type 2 diabetes patients.
    Detailed Description
    Poorly controlled type 2 diabetic men and women, aged between 20 and 80 years, with HbA1c≧ 7.5% (58mmol/mol) in the previous 3 months participated in this randomized controlled 18-month trial at a medical center. Patients were randomly assigned to the interventional group and given a 90g/day low carbohydrate diet (LCD) or the controlled group, which maintained a standard calorie-restricted diet (CRD). All patients received periodic educational intervention and were monitored for weight, body composition, waist girth, hip girth, thigh girth, pre- and post-prandial serum glucose, HbA1c, lipid profile(Cholesterol, Triglyceride. HDL, LDL, sdLDL), renal function, microalbumin/cre, carotid intima-media thickness (IMT),and medication effect score (MES).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Type 2 Diabetes Mellitus, Low carbohydrate diet

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized controlled trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low carbohydrate diet
    Arm Type
    Experimental
    Arm Description
    Low carbohydrate diet limits carbohydrate <=90g/day
    Arm Title
    Calori restricted diet
    Arm Type
    Active Comparator
    Arm Description
    Traditional diabetic diet
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Low carbohydrate diet
    Intervention Description
    For the LCD group, the daily carbohydrate intake was limited to less than 90g, without any restriction to total energy. The concept of a LCD was introduced and an educational 15 g equivalent carbohydrate food list was provided. The easy conversion method is that 15 g equivalent carbohydrate =1/4 bowel of rice= 1/2 bowel of noodle = 1 slice of toast = 3 soup-spoon of oats = one bowl of fruit =1/2 regular size banana= one glass of milk = 3 dumplings. Less than two equivalent 15g-carbohydrate intakes per meal were advised.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Calori restricted diet
    Intervention Description
    For the calori restricted diet group, the target total calorie intake was calculated by multiplying the ideal body weight by 25 kcal/kg for those with a BMI in the range 18.5 to 24, 20 kcal/kg for obese subjects with a BMI > 24 and 30 kcal/day for underweight subjects with a BMI <18.5. The macronutrient percentage was 50-60% for carbohydrate, 1.0-1.2 g/kg for protein and fat ≦30%.
    Primary Outcome Measure Information:
    Title
    The improvement of glycemic control status
    Description
    The reduction of HbA1c, fasting and 2-h glucose over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and every 3 months for 18 months after intervention
    Title
    The reduction of medication effect score (MES)
    Description
    The MES assessed the overall utilization of hypoglycemic agents. The percentage of the maximum daily dose for each medication was multiplied by an adjustment factor and these products were summed to produce the final MES value. A higher MES value denoted a greater use of medication. The minimum score is 0 and without maximum score.The lower, the better. The reduction of MES over the 18 months after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and every 3 months for 18 months after intervention
    Secondary Outcome Measure Information:
    Title
    The improvement of lipid profile
    Description
    The reduction of total cholesterol, triglyceride, LDL and the increment of HDL after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and every 3 months for 18 months after intervention
    Title
    The improvement of small dense low density lipoprotein (sdLDL)
    Description
    The reduction of sdLDL after intervention.The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and every 6 months for 18 months after intervention
    Title
    The maintenance of renal function
    Description
    The change of serum creatinine after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and every 3 months for 18 months after intervention
    Title
    The improvement of microalbuminuria.
    Description
    The reduction of microalbumin/creatine ratio after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and 18 month after intervention
    Title
    The improvement of carotid intima-media thickness (IMT)
    Description
    The reduction of carotid IMT after intervention. The analysis of generalized estimating equation parameters and empirical standard error estimates for the time-group difference over 18 months.
    Time Frame
    measured at baseline and 18 month after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Type 2 diabetes diagnosis ≧ 1 year poorly controlled with HbA1c≧ 7.5% in the previous 3 months. aged 20 to 80 without or with treatment [ oral hypoglycemic agents (OHA) and/or insulin treatment) Exclusion Criteria: pregnancy or lactating women impaired renal function with serum creatinine ≧ 1.5 mg/dl abnormal liver function [alanine aminotransferase (ALT), aspartate aminotransferase (AST), ≧ 3 times the normal upper limit) or liver cirrhosis significant heart diseases (unstable angina, unstable heart failure) frequent gout attacks (≧ 3 times/year) participation in other weight loss programs or the use of weight-reducing drugs eating disorders could not complete the questionnaire poor compliance to protocol.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chin-Ying Chen, MD, MHSc
    Organizational Affiliation
    National Taiwan University Hospital and National Taiwan University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effectiveness of Low Carbohydrate Diet in Reducing Polypharmacy for Patients With Type 2 Diabetes Mellitus

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